Stéphanie COLLOMB

En résumé

Entreprises

• Sanofi Pasteur MSD - European Qualified Person for Pharmacovigilance (EU QPPV) and Deputy Director, PVRM Group

  Paris 2015 - maintenant - Act as company named "Qualified Person" for Pharmacovigilance
  - Member of internal Management and Oversight Committees
  - Maintain and develop a European network of Pharmacovigilance contacts in subsidiaries of SPMSD
  - Oversight of all risk management plans, safety signals, safety communications, safety requests and aggregate reports for SPMSD countries and other aspects of the PV system as in current EU legislation
  - Lead the PVRM team in charge of young products and ensure timely execution of PVRM activities and fulfilment of all PV requirements of EU authorities for the young products
  

• Sanofi Pasteur MSD - Deputy Director, Pharmacovigilance and Risk Management and Deputy EUQPPV

  Paris 2013 - 2015 - Act as the deputy of the company named "Qualified Person" for Pharmacovigilance
  - Lead the PVRM team in charge of Risk Management, safety monitoring, aggregate reports, Health Authorities requests, safety communication, labelling and support to products franchise in life cycle management activities (SPMSD portfolio)
  

• Sanofi Pasteur MSD - Pharmacovigilance and Risk Management, Senior Division Manager

  Paris 2010 - 2013 - Manage a group of Vaccine Safety Officers and Managers in charge of safety monitoring and risk management activities.
  - Responsible for continuous monitoring of the safety profile of a defined portfolio of investigational and marketed vaccines, including safety concerns evaluation and action plans in collaboration with shareholders.
  - Oversee safety regulatory activities (review of periodic reports, safety variations, response to regulatory Authorities), contribute to risk management activities, prepare/review company safety documentation/communication regarding safety concerns.

• Sanofi Pasteur MSD - Unit Manager - Pharmacovigilance & Risk Management

  Paris 2007 - 2009 - Manage a PV team responsible for the case processing and safety evaluation of a portfolio of vaccines (individual and aggregate cases).
  - Supervise the PV activities related to clinical studies.

• Sanofi Pasteur MSD - Clinical Trials Unit Manager - Pharmacovigilance

  Paris 2004 - 2007 - Provide expertise, methodological and scientific support in the implementation, follow-up, and closure of PV activities in company sponsored clinical trials.
  - Evaluation and analysis of serious adverse events related to the use of investigational medicinal products. Writing of Annual Safety Reports (ASR).
  - Manage the Clinical Trials Unit team.

• Sanofi Pasteur MSD - Pharmacovigilant

  Paris 2001 - 2004

• QUINTILES (IRELAND) - Drug Safety Associate

  1999 - 2001

Formations

• IUP Ingénierie De La Santé

  Montpellier 1997 - 1999 Ingénieur Maître

Réseau

• Amandine COLLARD

• Florence PAPILLON

• France GOULLET

• Hélène BRICOUT

• Julien FOUQUE

• Loic FREREJOUAND

• Pauline MORTREUX

• Rosybel DRURY

• Sean TOMMISSEN

• Xavier CORNEN